FDA Offers Recommendations on Highlights Section of Labeling
By Michael Mezher -
Published 18 January 2018
The US Food and Drug Administration (FDA) on Thursday issued draft guidance providing recommendations on completing certain portions of the Highlights section of labeling for prescription drugs and biologics.
Categories: News, US, FDA, Biologics and biotechnology, Drugs, Labeling
Tags: Highlights, Prescribing Information, Physician Labeling Rule
ABPI Extends Astellas UK Suspension for 12 More Months
By Zachary Brennan -
Published 28 June 2017
The Association of the British Pharmaceutical Industry (ABPI) has announced that Astellas UK’s suspension as a member company has been extended for 12 more months as recent cases have shown a "lamentable lack of concern for patient safety."
Categories: News, Europe, Compliance, Crisis management, Ethics
Tags: ABPI, Astellas, prescribing information
FDA Proposal Calls for Drug Labeling to be Distributed to Doctors Electronically
By Alexander Gaffney, RAC -
Published 16 December 2014
In a long-anticipated and major move, the US Food and Drug Administration (FDA) has proposed a new rule requiring biopharmaceutical companies to distribute product labeling information to healthcare providers electronically.
Categories: News, US, CDER, Advertising and Promotion, Biologics and biotechnology, Drugs, Labeling
Tags: Drug Labeling, Proposed Rule, Rule, Regulation, Proposed Regulation, Professional Labeling, Prescribing Information